Forsteo® [Teriparatide]

Brand Eli lilly

In stock 505 Items

Available since: 2019-09-19

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Clinical Pharmacology

Forsteo is an analogue of parathyroid hormone. Recombinant human parathyroid hormone (PTH), obtained using Escherichia coli strain (using DNA recombination technology). Endogenous PTH, which is a sequence of 84 amino acid residues, is the main regulator of calcium and phosphorus metabolism in bones and kidneys. Forsteo (recombinant human PTH (1-34)) is an active fragment of endogenous human PTH. The physiological effect of PTH is to stimulate the formation of bone tissue through direct effects on osteoblasts. PTH indirectly increases intestinal absorption and tubular calcium reabsorption, as well as excretion of phosphates by the kidneys.

The biological effect of PTH is accomplished by binding to specific PTH receptors on the cell surface. Teriparatide binds to the same receptors and has the same effect on bone and kidney as PTH. Daily single injection of teriparatide stimulates the formation of new bone tissue on the trabecular and cortical (periosteal and / or endosteal) bone surfaces, with predominantly stimulating osteoblast activity relative to osteoclast activity. This is confirmed by the increase in the content of markers of bone tissue formation in the blood serum: bone-specific alkaline phosphatase and procollagen-I carboxyterminal propeptide (PICP). An increase in the content of markers of bone formation is accompanied by a secondary increase in the level of markers of bone resorption in urine: N-telopeptide (NTX) and deoxypyridinoline (DPD), which reflects the physiological interaction of the formation and resorption of bone tissue in skeletal remodeling.

Two hours after the administration of teriparapid, a short-term increase in the concentration of serum calcium is observed, which reaches maximum values after 4-6 hours and returns to baseline values within 16-24 hours. In addition, transient phosphaturia and a slight short-term decrease in serum phosphorus levels may occur .
During treatment with teriparatide, the bone mineral density (BMD) of the whole body increases by 5-10% (including in the lumbar spine, neck of the femur and femur).
Mineralization processes occur without signs of toxic action on bone tissue cells, and bone tissue formed under the influence of teriparapid has a normal structure (without the formation of reticulofibrous bone tissue and bone marrow fibrosis).
Teriparatide reduces the risk of fracture, regardless of age, baseline bone metabolism, or BMD (relative reduction of the risk of new fractures is 65%).

Pharmacokinetics
Suction and distribution
Teriparatide well absorbed when s / to the introduction. The absolute bioavailability of the drug is approximately 95%. Cmax of teriparatide is reached 30 minutes after s / c administration of the drug at a dose of 20 mcg and exceeds the level of PTH by 4-5 times, followed by a decrease in the concentration to undetectable values within 3 hours.
Vd is approximately 1.7 L / kg.
Like endogenous PTH, teriparatide does not accumulate in bones or other tissues.

Metabolism and excretion
T1 / 2 of teriparatide with sc injection is about 1 hour, which reflects the time required for absorption.
The peripheral metabolism of PTH occurs predominantly in the liver through nonspecific enzymatic mechanisms, followed by excretion by the kidneys.

Pharmacokinetics in special clinical situations
The effect of age (age group from 31 to 85 years) on the pharmacokinetics of teriparatide was not observed.
In patients with renal insufficiency of mild or moderate severity (CC from 30 to 72 ml / min), the pharmacokinetics of the drug does not change.

Indications

Treatment of osteoporosis in postmenopausal women; treatment of primary osteoporosis or osteoporosis due to hypogonadism in men.

Composition

1 ml solution for subcutaneous administration contains:
active substance: teriparatide 250 mcg,
Excipients: glacial acetic acid - 0.41 mg, anhydrous sodium acetate - 0.1 mg, mannitol - 45.4 mg, metacresol - 3 mg, 10% hydrochloric acid and / or sodium hydroxide solution 10% - q.s., water d / and - q.s. up to 1 ml.

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Dosage and Administration

Forsteo drug is prescribed for adults. The dose does not depend on the age of the patient.
The recommended dose of Forsteo is 20 mcg, injected 1 time per day subcutaneously in the thigh or abdomen area.
The maximum duration of treatment with Forsteo is 18 months. In the event of a break in treatment with Forsteo, patients may continue treatment with other drugs.
Additional prescription of calcium and vitamin D is recommended if they are supplied with food in insufficient quantities.
The patient should be trained in the technique of administering the drug (see “Manual on the use of a syringe pen”).

Terms of use pen
Forsteo is a solution in a pen for personal use. For each injection, a new sterile needle is required. Each Forsteo package contains a Patient Manual, which describes in detail the rules for handling a pen.
Injection needles not included. Syringe pen can be used with needles for insulin syringe pens (Becton Dickinson).
The drug should be administered immediately after the syringe pen is removed from the refrigerator.
After each injection, the pen should be placed in the refrigerator.

Adverse reactions

From the musculoskeletal system:very often (≥ 10%) - pain in the limbs; often (≥1%,

From the hemopoietic system:often (≥1%,

Metabolism:often (≥1%,

From the nervous system:often (≥1%,

From the psyche:often (≥1%,

The cardiovascular system:often (≥1%,

On the part of the respiratory system:often (≥1%,

From the digestive system:often (≥1%,

Skin and Subcutaneous Tissues:often (≥1%,

From the urinary system:rarely (≥ 0.1%,

Allergic reactions very rarely (<0.1%) - acute dyspnea, swelling of the mouth / face, generalized rash soon after injection.

General reactions:often (≥1%,

Local reactions: rarely (≥ 0.1%,

Contraindications

Carefully:

in patients in the phase of exacerbation of urolithiasis or recently had it, because of a possible deterioration of the condition; however, the excretion of calcium in the urine should be controlled;
in patients with moderate renal impairment;
hypovitaminosis D, clinically significant hypocalcemia.

Drug interactions

Clinically significant interactions with hydrochlorothiazide, furosemide, digoxin, atenolol, as well as with drugs with a slow release - diltiazem, nifidipine, felodipine, nisoldipine was not observed.
The joint appointment of teriparatide with raloxifene or hormone replacement therapy does not affect the content of calcium in serum and urine.
A single administration of teriparatide has no effect on the pharmacodynamics of digoxin. Hypercalcemia is a predisposing factor to the development of intoxication with digitalis, therefore teriparatide should be used with caution in patients taking digitalis.

Pregnancy and Lactation

The effect of treatment with teriparatide on the development of the fetus in humans has not been studied. Do not prescribe a drug during pregnancy.
No clinical studies have been conducted to determine whether teriparatide is excreted in breast milk. Teriparatide should not be given to nursing mothers.

Special instructions

The effect of teriparatide in patients with hypercalcemia has not been studied, so the drug should not be prescribed to such patients because of the possibility of exacerbation of hypercalcemia.
Before starting treatment with teriparatide, hypercalcemia should be excluded; however, regular monitoring of serum calcium concentration is not required.
The effect of teriparatide in patients with active urolithiasis has not been studied. Patients with urolithiasis (acute or recent exacerbation) should not use teriparatide because of the risk of exacerbation of the disease.
Blood sampling for the determination of calcium in the blood should be made not earlier than 16 hours after the last injection of the Forsteo drug, since There may be a short-term increase in serum calcium after injection of teriparatide. Constant monitoring of the calcium concentration during treatment is not required.
When taking the drug Forsteo, rare episodes of short-term orthostatic hypotension may occur, which occur within 4 hours after drug administration and go away on their own for from several minutes to several hours when the patient is placed in a supine position and are not a contraindication to further treatment.
Due to the lack of clinical data with long-term treatment with teriparatide, the recommended duration of treatment should not exceed 18 months.
Forsteo should not be used if the solution in the syringe pen is cloudy, colored or contains foreign particles.

Use in Pediatrics
The effect of teriparatide in pediatric patients has not been studied. Teriparatide should not be used in pediatric patients, adolescents or young people with open epiphyseal growth zones.

Overdosage

Symptoms: overdose can be manifested by prolonged hypercalcemia and the development of orthostatic collapse. Nausea, vomiting, dizziness, headache are also possible.

Treatment: there is no special antidote. If an overdose is suspected, it is recommended that Forsteo be withdrawn, control serum calcium and perform symptomatic therapy.